About this trial
Suicide is the leading cause of death amongst 10-18-year-olds in Sweden. Suicide attempts are the strongest predictor of subsequent death by suicide, often lead to inpatient care, and are associated with substantial societal costs, making suicide attempts a critical target in psychiatric intervention research. Although youths attempting suicide are typically assessed and treated for potential comorbid psychiatric conditions, there is currently no trans-diagnostic evidence-based treatment specifically targeting suicidal behavior. To fill this gap, the Safe Alternatives for Teens and Youths (SAFETY) was developed. SAFETY is a transdiagnostic family-based cognitive-behavioral suicide prevention program that has shown promise but more studies are needed.
The overall objective of this project is to evaluate the efficacy, durability, and cost-effectiveness of the SAFETY intervention, a scalable suicide prevention intervention that can be offered immediately following a youth suicide attempt, in a fully powered single-blind randomized controlled superiority trial. Our primary hypothesis is that the SAFETY intervention will be superior to Enhanced Treatment As Usual (enhanced with the evidence-based intervention safety planning) in reducing the proportion of suicide reattempts. Moreover, we predict that these improvements will be maintained for up to 60 months post-treatment. Finally, we expect that SAFETY will be cost-effective compared to the control intervention, both at the primary endpoint and in the longer term.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suicide attempt in the last 3 months
Age 10-17 years
At least one primary caregiver (multiple is allowed) willing to participate in treatment
Disqualifiers
Symptoms obstructing participation in assessments or treatment
Insufficient understanding of the Swedish language in youth and/or caregiver
Enrolled in Dialectical Behavioral Therapy
Trial design
Parallel
Treatments tested in this trial
Safe Alternatives for Teens and Youth (SAFETY)
BehavioralPlease see description of experimental arm (arm one)
Enhanced Treatment As Usual
BehavioralPlease see description of active comparator arm (arm two).
Treatment groups
Trial outcomes
Primary outcomes
Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records
Any report of suicide attempt, using data collected from: 1. Youth-report of the C-SSRS. The C-SSRS is a 22-item structured clinical interview assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm. 2. Caregiver-report of the C-SSRS (reduced 4-item version including only the suicidal behavior section). 3. Electronic medical records.
Secondary outcomes
Nonsuicidal self-injury - any report from The Deliberate Self Harm Inventory - Youth version (DSHI-Y)
The DSHI-Y used in this trial is a 8-item clinican-rated interview that will be used to assess presence and frequency (0 to ∞) of non-suicidal self-injury, where a higher score indicates higher frequency of non-suicidal self-injury. One item measuring non-suicidal intoxications has been added to the original DSHI-Y. The DSHI-Y is adapted for adolescents from the DSHI an empirically supported measure of various aspects of NSSI originally developed for use with adults. The DSHI has demonstrated good test-retest reliability and adequate concurrent validity among adolescents. For youths who decline participation in follow-up interviews, a one-item version of the DSHI-Y assessing presence of any nonsuicidal self-injury will be administered to the youth's caregiver when caregiver report is available.
Work and Social Adjustment Scale, youth version (WSAS-Y)
WSAS-Y is a clinician-rated scale of impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. The scale generates a global score ranging from 0 to 40, with higher scores indicating greater impairment.
Children's global assessment scale (CGAS)
The CGAS is a clinician rated single item 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent better functioning.
Revised Children's Anxiety and Depression Scale, 25 item version (RCADS-25)
The RCADS-25, a shortened version of the Spence Child Anxiety Scale, is a child self-report measure of anxiety- and depression-related psychopathology, with six subscales; separation anxiety, social anxiety, generalized anxiety, panic disorder, obsessive-compulsive disorder and major depressive disorder, as well as a total anxiety-scale. Total range is 0-45, Likert scale ranging from 0-3, with higher values representing a worse outcome.
Other outcomes
Self-harm
Composite outcome of suicide attempts (C-SSRS, medical records) and nonsuicidal self-injury (DSHI-Y) ranging from (0 to ∞), in order to enable comparison with other studies.
Borderline Personality Feature Scale for Children-11 (BPFS-C-11)
The BPFS-C-11 is a youth-rated 11-item measure of borderline personality features for children 9 - 18 years old. The BPFS-C-11 includes indicators of borderline pathology such as affective instability, identity problems, and negative relationships. Item responses are on a 5-point Likert scale, yielding a range of 11-55, with higher scores indicating higher levels of borderline features.
Levels of Personality Functioning Questionnaire 12-18 (LoPF-Q 12-18)
LoPF-Q 12-18 is a youth-rated 20-item measure rated on a scale of 0-4, yielding a range of 0-80, where a higher score indicates higher impairment in personality functioning. LoPF-Q is developed for use in adolescent populations between 12 and 18 years to assess the dimensions of personality functioning: identity, self-direction, empathy, and intimacy.
Borderline Symptom List Supplement (BSL-Supplement)
The BSL-Supplement is a youth-rated 9-item measure of self-destructive behaviors under the past 7 days, with answers ranging from "Not at all" to "Daily or even more often". Higher scores indicate a higher frequency of self-destructive behaviors.
Sponsors and contacts
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